The central government has directed that medicines containing a combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride should not be given to children below four years of age, citing safety concerns associated with the drug combination.

The restriction was issued on Saturday following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The government said the measure is intended to protect young children from potential health risks linked to the use of the combination.

The latest order applies to Fixed Dose Combination (FDC) medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. Pharmaceutical companies will now be required to ensure that these medicines carry a clear warning against their use in children under four.

Warning To Be Displayed

The government has made it mandatory for manufacturers to prominently display the warning on medicine packaging, package inserts and promotional material.

The warning must clearly state that the medicines should not be used in children below four years of age. The requirement is intended to ensure that parents, caregivers and healthcare professionals are aware of the age restriction before the medicines are used.

Experts have raised safety concerns about the use of the combination in very young children, while safer treatment options are available for this age group.

Order Under Drugs Act

The latest directive has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to regulate or restrict the manufacture, sale or distribution of certain medicines when such action is considered necessary in the public interest.

The move follows an earlier government notification issued on April 15, 2025, concerning warnings on certain Fixed Dose Combination medicines.

The latest order expands the age-specific restriction to all FDC medicines containing the Chlorpheniramine Maleate and Phenylephrine Hydrochloride combination for children below four years.

What Are FDC Medicines?

Fixed Dose Combination medicines contain two or more active pharmaceutical ingredients in specific quantities in a single formulation. Such combinations are commonly developed to address multiple symptoms or therapeutic requirements through one medicine.

Under the latest directive, manufacturers of FDC medicines containing the specified combination must comply with the new age-related warning requirements.

The government has also made clear that these medicines should not be used for children under four years of age. Parents and caregivers should check the age-related warnings on medicine packs and consult a qualified healthcare professional before giving medicines to young children.

The restriction comes amid continued regulatory scrutiny of medicines intended for children, particularly combinations used for cold and cough symptoms, where age-appropriate safety remains a key concern.